1. Field of the Invention
The present invention is an implant utilized in nasal reconstructive surgeries. In the primary mode, the device is intended to provide support for the external nasal valve when natural cartilage is insufficient due to prior poorly-performed rhinoplasty, trauma, defects, or age. In this preferred mode, the device is an elongated, concave, oval-shaped member, preferably constructed of a porous polyethylene. A unique method of the implantation thereof is also provided, wherein the implant is placed through an external rhinoplasty approach. More particularly, residual lower lateral cartilage is removed, the implant is inserted into an external valve pocket formed by the same, staying in place due to soft tissue therearound, and the nasal tip is re-draped. In total, usage of the foregoing allows patients to experience significant improvement in breathing and airway management following the external nasal valve reconstruction procedure.
2. Description of the Prior Art
Many innovations for nasal implants and polyethylene devices are provided in the prior art, described as follows. Although these inventions are suitable for the purposes they address, they differ from the present invention as contrasted herein. Following is a summary of patents most relevant to the invention at hand, including description of differences between features of the invention and those of the prior art.
1. U.S. Pat. No. 4,938,234, Invented by Capriotti, Entitled xe2x80x9cMethod Of Surgically Implanting A Contour Nasal Implantxe2x80x9d
In the patent to Capriotti, a method is disclosed for surgically implanting a contour nasal implant into a nose of a patient to elevate the nasal tip and to augment and to improve the frontal and profile views of the patient""s nose. The method comprises the steps of drawing, onto the nose of a patient into which a contour nasal implant is to be surgically implanted, a line connecting the highest points of the superior palpebral sulci such that the line crosses the nasal dorsum at a point representing the nasion and the highest point of implant insertion; placing two pledgets in each nostril in the nose of the patient; performing an open rhinoplasty incision into the skin located between the nostrils of the patient; retracting superiorly the columella skin off of the lower lateral cartilages on each side of the nostril up to the highest point of the natural dome of the nose of the patient; dissecting the skin off of the dorsum of the nose to the line previously drawn across the nasal dorsum; inserting a contour nasal implant having an elongated central member having a dorsal section, a predetermined shaped tip and a keel having a selected width and length which is located under the predetermined shaped tip with the keel thereof extending downward between the lower lateral cartilage until the desired implantation position is obtained; and suturing the rhinoplasty incision in the skin between the nostrils.
2. U.S. Pat. No. 5,030,232, Invented by Pham, Entitled xe2x80x9cNasal Implant Device With Improved Contourxe2x80x9d
The nasal implant of the Pham invention is characterized by a composition of hard-grade silicone fashioned into a special shape. One variation in the composition material is to use soft silicone only for the tip in order to overcome the fear of some surgeons to use hard silicone in this particular area. A special and improved shape of the implant, in the form of a modified hourglass, provides a well rounded and larger tip portion thanb that of the prior art. The supra-tip of this improved implant shows a depression dorsally, is less wide than the rest of the implant and has a pronounced slope laterally. These features, particularly at the supra-tip region avoid the unnatural effects of the prior art devices. Moreover this implant has a variable thickness form upper end to tipxe2x80x94that is it starts thin, increases in thickness and then goes thinner againxe2x80x94whereas the prior art starts thin and continually increases throughout.
3. U.S. Pat. No. 5,112,353, Invented by Johansson et al., Entitled xe2x80x9cContour Nasal Implantxe2x80x9d
In the patent to Johansson et al., a contour nasal implant adapted to be used in rhinoplasty surgery is shown. The contour nasal implant includes an elongated, central member having a first end and a second end wherein the second end is spaced a predetermined distance from the first end. The first end of the elongated central member is flared to define a dorsal support end or dorsal section which is adapted to be positioned over the nasal dorsum in the nose of a patient to augment the frontal and profile views of the nose along the nasal dorsum. The second end includes a tip having a predetermined shape which is located on the same side of the elongated central member as the dorsal support end. A second end includes a keel having a selected width and length and the keel is located on the second end under the predetermined shaped tip. The keel is positioned substantially perpendicular to the elongated central member and is positioned such that the length of the keel is generally parallel to the elongated central member. The tip is operative, when implanted into the nose of a patient, to reshape and elevate the nasal tip of the nose of a patient. The tip and the dorsal support end contour and shape the frontal and profile views of the nose of a patient.
4. U.S. Pat. No. 4,994,084, Invented by Brennan, Entitled xe2x80x9cReconstructive Surgery Method And Implantxe2x80x9d
The Brennan invention describes a homograft implant made from prepackaged, processed homograft material. The homograft material is taken in its purchased dehydrated form and cut into strips of varying shapes and sized. The strips are then adhesively secured together in a laminar manner by a tissue adhesive to form the desired shape and density of the implant. Once the implant has been made, it may then be surgically implanted in a desired location, immediately beneath the patient""s dermis so as to alter the exterior appearance of the patient at the implant site. Since the implant is formed of dehydrated homograft material, endogenous tissue readily attaches to the implant after a short period of time, so that the implant becomes integral with the body.
5. U.S. Pat. No. 5,876,435, Invented by Swords et al., Entitled xe2x80x9cCoupling for Porous Resin Orbital Implant and Ocular Prosthesisxe2x80x9d
In the patent to Swords et al. an improved coupling method and device for an ocular prosthesis to a porous polyethylene implant is provided. According to the invention, a small surgical screws having a domed head is inserted into a porous plastic implant after the implant has been implanted into an enucleated orbit allowed to vascularize. The domed head projects from the anterior surface of the implant which is covered by conjunctive tissue and is received by a complementary cavity on the rear surface of the ocular prosthesis.
6. U.S. Pat. No. 5,053,050, Invented Itay, Entitled xe2x80x9cCompositions for Repair of Cartilage and Bonexe2x80x9d
In the patent to Itay, a defect is provided in cartilage or bone, or both, to excize damaged or pathological tissue, and it is filled with an implant having capability for complete regeneration of the skeletal tissue as a chondrogenic or osteogenic phenotype. The implant comprises cells expressing a chondrocyte phenotype (80xc3x97106 cells/ml) embedded in a biocompatible matrix having about 20% serum, which provides a permissive environment for maturation and transformation of the implant to a fully integrated state with the surrounding tissue. A portion of the implant may comprise a bone segment or a bone substitute.
7. U.S. Pat. No. 5,786,217 Invented by Tubo et al., Entitled xe2x80x9cMethods and Compositions for the Repair of Articular Cartilage Defects in Mammalsxe2x80x9d
Provided in the patent to Tubo et al. are methods and compositions for the repair of articular cartilage defects in a mammal. Denuded chondrogenic cells are proliferated ex vivo as monolayer cultures in order to expand the pool of available chondrogenic cells. During proliferation the chondrogenic cells stop secreting the extracellular matrix components, type II collagen and sulfated proteoglycans. The proliferated cells then are seeded into a pre-shaped well having a cell contacting, cell abhesive surface. The cells cultured in the well redifferentiate and begin to secrete cartilage-specific extracellular matrix again. Accordingly, essentially unlimited amounts of synthetic cartilage may be prepared from small samples of biopsy tissue. Also provided are methods for surgically repairing articular cartilage defects in mammals using the synthetic cartilage prepared in accordance with the invention.
8. U.S. Pat. No. 5,842,477, Invented by Naughton et al., Entitled xe2x80x9cMethod for Repairing Cartilagexe2x80x9d
The Naughton et al. invention relates to methods of making and/or repairing cartilage in vivo comprising implanting into a patient, at a site of cartilage damage or loss, a biocompatible, non-living three-dimensional scaffold or framework structure in combination with periosteal/perichondrial tissue that can be used to hold the scaffold in place and provides a source of chondrocyte progenitor cells, chondrocytes and other stromal cells for attachment to the scaffold in vivo. In addition, a preparation of cells that can include chondrocytes, chondrocyte progenitor cells or other stromal cells is administered, either before, during or after implantation of the scaffold and/or the periosteal perichondrial tissue; the cells are administered directly into the site of the implant in vivo and promote the induction of factors that enhance chondrogenesis and the migration of chondrocytes, progenitor cells and other stromal cells from the adjacent in vivo environment into the scaffold for the production of new cartilage at the site of implantation.
9. U.S. Pat. No. 5,916,557, Invented by Berlowitz-Terrant et al., Entitled xe2x80x9cMethods Of Repairing Connective Tissuesxe2x80x9d
The Berlowitz-Terrant et al. invention relates to the use of an ECM-altering enzymatic activity, such as a proteoglycanase or a protease, to stimulate the generation of cartilage tissue by inducing chondrocytes to synthesize new cartilage matrix. It has been discovered that treating chondrocytes with an enzymatic activity that modifies the territorial ECM of the cell, especially cell surface proteoglycans, can in and of itself be sufficient to stimulate cartilage production by the chondrocytes. The subject invention can be employed therapeutically to correct or prevent degeneration of connective tissue. For instance, the present method can be used in the treatment of disorders comprising cartilage such as found in an diarthroidal joint (e.g. articular and interarticular cartilage), as well as in the treatment of tendon and ligamental tissues. Such disorders can range from chronic degeneration brought about by disease, overuse, or trauma, to plastic or reconstructive surgery. Moreover, the subject method may also be applied to both the development and implantation of prosthetic devices.
10. U.S. Pat. No. 5,041,138, Invented by Vacanti et al., Entitled xe2x80x9cNeomorphogenesis Of Cartilage In vivo from Cell Culturexe2x80x9d
The patent to Vacanti et al. describes methods and artificial matrices for the growth and implantation of cartilaginous structures and surfaces. In the preferred embodiments, chondrocytes are grown on biodegradable, biocompatible fibrous polymeric matrices. Optionally, the cells are proliferated in vitro until an adequate cell volume and density has developed for the cells to survive and proliferate in vivo. One advantage of the matrices is that they can be cast or molded into a desired shape, on an individual basis, so that the final product closely resembles a patient""s own ear or nose. Alternatively, flexible matrices can be used which can be manipulated at the time of implantation, as in a joint, followed by remodeling through cell growth and proliferation in vivo. The cultured cells can also be maintained on the matrix in a nutrient media for production of bioactive molecules such as angiogenesis inhibiting factor.
11. U.S. Pat. No. 6,001,352, Invented by Boyan et al., Entitled xe2x80x9cResurfacing Cartilage Defects with Chrondrocytes Proliferated without Differentiation Using Platelet-Derived Growth Factorxe2x80x9d
In the patent to Boyan et al., a method for stimulating chondrocyte proliferation and inhibiting chondrocyte differentiation along the endochondral developmental pathway is provided comprising contacting condrocytes with an effective amount of Platelet-Derived Growth Factor (PDGF) such as PDGF-BB, PDGF-AA OR PDGF-AB in the substantial absence of growth factors which promote cell differentiation. This allows such cells to be multiplied in culture for loading onto a scaffolding material and implanting into a cartilage or bone wound.
As outlined above, the prior art patents that relate to implants and nasal reconstructive surgeries largely entail elements such as: a nasal implant with composition of hard-grade silicone fashioned into a special shape with soft silicone used only for the tip; a homograft implant made from prepackaged and processed homograft material in dehydrated form and cut into strips of varying shapes and sizes; a porous polyethylene implant used in connection with an ocular prosthesis; a method for stimulating chondrocyte proliferation; methods where chondrocytes are grown on biodegradable fibrous polymeric matrices; and various other traditional implantation devices and methods.
In contrast to all of the above, the present invention is an elongated, concave, oval-shaped implant, constructed of a porous polyethylene, to be utilized in nasal reconstructive surgeries. A unique method allows for a convenient implantation means that has significant cosmetic benefits. In addition, usage of the foregoing allows for significant improvement in breathing and airway management following the external nasal valve reconstruction procedure.
As noted, the present invention is an implant utilized in nasal reconstructive surgeries, especially to provide support for the external nasal valve when cartilage is insufficient. In the preferred mode, the device is concave and oval-shaped, constructed of a porous polyethylene. Usage of the foregoing allows patients to experience improvement in breathing and airway management in addition to an improved appearance.
Thus, the implant of the present invention is intended to repair compromised skin-soft tissue envelopes which are secondary to such things as congenital defects, prior rhinoplasty surgery, heavy smoking, cocaine abuse, or simple adverse effects of aging.
According to the foregoing, it is an object of the present invention to restore or improve the patient""s respiratory function.
It is a further goal of the present invention to provide reestablishment of the desired aesthetic nasal contour.
As such, it is a specific object of the present invention to allow for fibrovascular ingrowth, which lends great stability to the implant.
It is a particular aim of the applicant to provide a structurally stable implantation device that does not shift, rotate, or otherwise change position following installation.
It is a goal of the applicant to provide a device that elicits minimal inflammation, and resists trauma and exposure.
Similarly, it is a goal of the applicant to provide an implant that is non-carcinogenic and antigenically inert.
It is an additional object of the invention to overcome the detriments related to cartilage used for optimal grafting material, such limited supply, time restraints, and morbidity associated with harvesting.
It is an additional object of the present invention to overcome the detriments related to synthetic materials with high infection and extrusion rates.
It is also an object of the present invention to allow for effective reconstruction while alleviating implant extrusion and skin erosion.
It is a goals of the invention to provide a device that may be used effectively in relatively thin-skinned areas, performing far better in said areas than silicone implants widely known in the art.
It is an object of the present invention to provide implants that may be easily removed postoperatively.
Further, it is an object of the invention and procedure to mitigate the level of swelling and recovery time associated with nasal reconstruction.
It is an object of the present invention to provide an implant which may be manufactured or configured in a number of shapes and sizes for the utmost in versatility.
It is an additional object of the invention to provide an implant which may be used in conjunction with additional implants during the same procedure.
In total, the novel features considered characteristic for the invention are set forth in the claims. The invention itself both as to its construction and method of operation, will be best understood from the following description of the embodiments when read and understood in connection with the drawings provided.